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| Name | Class |
|---|---|
| Allina Health System | OTHER |
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This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography. The purpose is to find out how useful plain x-rays are in open posterior lumbar spine surgery, information which is presently unavailable. The specific aim is to compare the sensitivity (seeing a sponge when one is actually present) and specificity (not seeing a sponge when one is not present) of radiography of the surgical field for three conditions: viewing one lateral radiograph versus viewing one anteroposterior radiograph versus viewing two radiographs together, one lateral and one anteroposterior.
This is a prospective, randomized study with two cohorts: one experimental and one control. Anteroposterior (AP) and lateral (LAT) radiographs are routinely obtained as standard of care during spine surgery to confirm proper implant placement. These images will be used in this study. In one-half of the study subjects, after all sponges are removed, a surgical sponge will be intentionally placed in the surgical field prior to imaging. Postoperatively, each subject's images will be assessed for the presence or absence of a retained surgical sponge. Images will be independently read by two investigators. When there is discordance, the images will be adjudicated by a third. Interobserver agreement will be quantified using the Kappa statistic. Those reading images will not have participated in the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retained Sponge Group | Experimental | Just prior to imaging, the surgeon will purposely place a sponge in the wound. Two radiographs will be taken of the spine (AP and Lateral views). |
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| No Retained Sponge Group | No Intervention | No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retained Surgical Sponge | Other | A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together. | Intraoperative |
| Interobserver Reproducibility | Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations | Intraoperative |
| Intraobserver Reproducibility | Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself | Intraoperative |
| Sensitivity | Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present | Intraoperative |
| Specificity | Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir A Mehbod, MD | Twin Cities Spine Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Twin Cities Spine Center | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18589366 | Background | Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008 Jul;207(1):80-7. doi: 10.1016/j.jamcollsurg.2007.12.047. Epub 2008 May 23. | |
| 17275034 | Background | Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, Heniford BT. Retained foreign bodies after surgery. J Surg Res. 2007 Apr;138(2):170-4. doi: 10.1016/j.jss.2006.08.001. Epub 2007 Feb 1. |
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There is not a plan to make individual participant data (IPD) available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retained Sponge Group | A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge. |
| FG001 | No Retained Sponge Group | No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Retained Sponge Group | A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge. |
| BG001 | No Retained Sponge Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy | Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together. | Posted | Number | Cohen's Kappa | Intraoperative | Images | Images |
|
Intraoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retained Sponge Group | A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Twin Cities Spine Center | 612-775-6222 | jmdawson@tcspine.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2018 | Oct 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005547 | Foreign Bodies |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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This is a prospective, randomized study with two cohorts: one experimental and one control.
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This is a semi-blinded trial. Investigators performing the surgery will know whether or not a sponge is present but the investigators reviewing the images will not. Subjects will not be told which study group they are in.
| 29807184 | Background | Turgut M, Akhaddar A, Turgut AT. Retention of Nonabsorbable Hemostatic Materials (Retained Surgical Sponge, Gossypiboma, Textiloma, Gauzoma, Muslinoma) After Spinal Surgery: A Systematic Review of Cases Reported During the Last Half-Century. World Neurosurg. 2018 Aug;116:255-267. doi: 10.1016/j.wneu.2018.05.119. Epub 2018 May 26. |
| 15883903 | Background | Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3. |
| 6622683 | Background | Revesz G, Siddiqi TS, Buchheit WA, Bonitatibus M. Detection of retained surgical sponges. Radiology. 1983 Nov;149(2):411-3. doi: 10.1148/radiology.149.2.6622683. |
| 12954688 | Background | Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453. |
| 29420322 | Background | Hellbach K, Beller E, Schindler A, Schoeppe F, Hesse N, Baumann A, Schinner R, Auweter S, Hauke C, Radicke M, Meinel FG. Improved Detection of Foreign Bodies on Radiographs Using X-ray Dark-Field and Phase-Contrast Imaging. Invest Radiol. 2018 Jun;53(6):352-356. doi: 10.1097/RLI.0000000000000450. |
No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
Lateral and Anteroposterior x-rays of surgical field view together |
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| Primary | Interobserver Reproducibility | Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations | Posted | Number | Cohen's Kappa | Intraoperative | Images | Images |
|
|
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| Primary | Intraobserver Reproducibility | Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself | Posted | Number | Cohen's Kappa | Intraoperative | Images | Images |
|
|
|
| Primary | Sensitivity | Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present | Posted | Number | percentage of correct interpretations | Intraoperative | Images | Images |
|
|
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| Primary | Specificity | Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present | Posted | Number | percentage of correct interpretations | Intraoperative | Images | Images |
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| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | No Retained Sponge Group | No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views). | 0 | 55 | 0 | 55 | 0 | 55 |
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